pifenidone prophylactic therapy for radiation lung injury in patients who have previously received immune checkpoint inhibitors

Conditions: Lung Cancer

Summary: patients with advanced lung cancer who have previously received immunocheckpoint inhibitor therapy, undergone chest radiation therapy again have developed radiation induced lung injury. pirfenidone has anti-inflammatory and anti fibrosis effects. this study is intended to evaluate the effectiveness of pirfenidone combined with radiotherapy in the prevention of radiation pneumonitis.


Eligibility criteria:
inclusion criteria: 1. the patients joined the study voluntarily and signed an informed consent form (icf). they had good compliance and cooperated with follow-up; 2. patients with lung cancer who had received at least 2 cycles of immunomonotherapy or combination systemic therapy (including pd-1 or pd-l1 immunocheckpoint inhibitors) within 6 months; 3. age ≥ 18 years, no gender limit; 4. ecog ps score: 0～1; 5. the expected survival time ≥ 3 months; 6. use appropriate methods of contraception or surgical sterilization during treatment and for 3 years after treatment for men and women of reproductive age； 7. appropriate biochemical indicators and organ function. exclusion criteria: 1. currently participating in interventional clinical research and treatment, or receiving other research drugs or treatment with research equipment within 4 weeks before the first administration; 2. accept solid organ or blood system transplantation; 3. suffer from active autoimmune diseases that require hormone or immunomodulatory treatment, such as rheumatoid arthritis, ankylosing spondylitis, type i diabetes, psoriasis, vitiligo, immune-related thyroid dysfunction, etc. (hormone replacement can be included after treatment is normal); 4. suffer from acute or chronic infectious diseases, such as hepatitis b, hepatitis c, tuberculosis, and hiv; 5. allergic to research drug ingredients; 6. active infection or fever of unknown cause occurred during the screening period and before the first administration\> 38.5℃ (according to the judgment of the investigator, the subject can be included in the group due to fever caused by the tumor); 7. suffer from uncontrolled clinical symptoms or diseases of the heart, such as:(1) heart failure above nyha ii; (2) unstable angina pectoris; (3) myocardial infarction occurred within 1 year; (4) patients with clinically significant supraventricular or ventricular arrhythmia requiring clinical intervention; 8. suffer from high blood pressure and cannot be well controlled by antihypertensive medication (systolic blood pressure ≥150 mmhg or diastolic blood pressure ≥100 mmhg); 9. abnormal blood coagulation function (inr\>2.0, pt\>16s), have a bleeding tendency or are receiving thrombolytic therapy, and allow preventive use of low-dose aspirin and low-molecular-weight heparin; 10. obvious coughing up blood or hemoptysis of 10ml or more per day in the 2 months before enrollment; 11. have significant clinically significant bleeding symptoms or have a clear bleeding tendency within 3 months before enrollment; 12. have received anti-tumor monoclonal antibodies (mab) within 4 weeks before using the study drug for the first time, or the adverse events caused by the previously received drug have not recovered (ie ≤ grade 1 or reached the baseline level). note: except for subjects with ≤ grade 2 neuropathy or ≤ grade 2 hair loss, if the subject has undergone major surgery, the toxic reaction and/or complications caused by the surgical intervention must be fully recovered before starting treatment; 13. the investigator judged other situations not suitable for inclusion in this study.